OncoMatch/Clinical Trials/NCT04427293
Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)
Is NCT04427293 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Lenvatinib and Pembrolizumab for triple negative breast cancer.
Treatment: Lenvatinib · Pembrolizumab — This is single arm study of a window of opportunity in which participants with previously untreated triple negative breast cancers (TNBC) who are candidates for potentially curative surgery will receive lenvatinib 12 mg daily for 7 and pembrolizumab 200 mg IV on day 1 prior to surgery
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 wild-type (≤10% of tumor cells staining for ER by IHC)
Estrogen Receptor (ER)- and Progesterone Receptor (PR)-negative as determined by immunohistochemistry (IHC)
Required: PR (PGR) wild-type (≤10% of tumor cells staining for PR by IHC)
Estrogen Receptor (ER)- and Progesterone Receptor (PR)-negative as determined by immunohistochemistry (IHC)
Required: HER2 (ERBB2) wild-type (HER2-negative, as defined by ASCO/CAP guidelines)
HER2-negative, as defined by ASCO/CAP guidelines
Disease stage
Required: Stage T1B-T3, N0-N3 (AJCC 8th edition)
AJCC 8th edition clinical stage T1b-T3/N0-N3/M0 by physical exam or radiologic studies
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: cytotoxic chemotherapy
Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer
Cannot have received: immunotherapy
Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer
Cannot have received: biologic therapy
Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer
Cannot have received: radiation therapy
Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer
Cannot have received: investigational agent
Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer
Cannot have received: VEGFR inhibitor (lenvatinib)
Previous treatment with lenvatinib or any immune checkpoint inhibitor within the past 2 years
Cannot have received: checkpoint inhibitor
Previous treatment with lenvatinib or any immune checkpoint inhibitor within the past 2 years
Lab requirements
Blood counts
Leukocytes ≥2,500/mm3; Platelet count ≥ 100,000/mm3; ANC ≥ 1,500/mm3; Hemoglobin (Hgb) ≥ 9.0 g/dL
Kidney function
Creatinine < 1.5 x ULN or CrCl ≥ 50 mL/min using Cockcroft-Gault formula
Liver function
Bilirubin ≤ 1.5 × ULN (Gilbert's syndrome exception); AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN
Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 30 days prior to registration Hematological Leukocytes ≥2,500/mm3 Platelet count ≥ 100,000/mm3 Absolute Neutrophil Count (ANC) ≥ 1,500/mm3 Hemoglobin (Hgb) ≥ 9.0 g/dL Renal Creatinine/Calculated creatinine clearance (CrCl) Cr < 1.5 x upper limit of normal (ULN) or CrCl ≥ 50 mL/min using the Cockcroft-Gault formula Hepatic Bilirubin Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin > 1.5 × ULN, if no evidence of biliary obstruction exists Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Illinois · Chicago, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04427293 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 wild-type is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR wild-type is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage T1B-T3 or N0-N3 is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify